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Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

Primary Purpose

Hypertension, Pregnancy-Induced, Hypertension in Pregnancy, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Meditation
conventional treatment
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pregnancy-Induced focused on measuring systemic arterial hypertension, hypertension, hypertension, pregnancy-induced, pre-eclampsia, meditation, randomized clinical Trial

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pre-existing hypertension.
  2. Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
  3. Prenatal follow-up in a high-risk pregnancy clinic.
  4. No personal background of depression or psychiatric disorders.
  5. No serious heart disease.
  6. No illicit drugs and/or alcohol use.
  7. Acceptance of the informed consent.
  8. To follow the practice used in the study, the subjects are required to have an available phone in order to download an app which contains an audio guide for this purpose.

Exclusion Criteria:

  1. Diagnosis of depression and psychiatric disorders during pregnancy.
  2. Patients who do not return to follow-up or who want to quit the study.
  3. To practice meditation.

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Meditation group

conventional treatment

Arm Description

Patients who are going to practice meditation and will receive only the usual outpatient care, with the aim of observing reduction of systemic blood pressure in this period.

Patients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period.

Outcomes

Primary Outcome Measures

Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
Diastolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
Systolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The systolic pressure check will be in outpatient consultation with intervals of 15 days, during. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.

Secondary Outcome Measures

Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.
Checking potential increases or decreases in the quality life indicator during pregnancy using the Whoqol-Bref questionnaire as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. This questionnaire is composed of four domains of quality of life, totaling 24 questions. The answers follow a Likert scale (from 1 to 5) and the domain scores for the WHOQOL-BREF were calculated by multiplying the mean of all items included within the domain by four. Potential scores for all domain scores, therefore, range from 4-20. Only the total quality of life score will be considered in this study. For this study, a larger score on the Whoqol-Bref demonstrates a better outcome for the group performing the meditation intervention.
Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).
Checking potential increase or decreases of anxiety and depression indicators during pregnancy using the HADS Scale as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Hospital Anxiety and Depression Scale (HADS) consist of 14 questions. It was divided into an Anxiety subscale (HADS-A) consist of 07 questions and a Depression subscale (HADS-D) consist of 07 questions both containing seven intermingled items. Each items can be scored from zero (0) to three (3), composing a maximum score of 21 points for each sub-scale. HAD-anxiety: no anxiety from 0 to 8, with anxiety ≥ 9; HAD-depression: without depression from 0 to 8, with depression ≥ 9. For this study, a larger score on the Resilience Scale demonstrates a worst outcome for the group performing the meditation intervention.
Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.
Checking potential increase or decreases of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress, during pregnancy using the Resilience Scale as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Resilience Scale is the scale that consist of 25 questions concerning the capacity to adapt and restore equilibrium to their lives to be rated on a 7-point scale The Likert scale ranged from (1) disagree to (7) agree, with higher scores reflecting higher levels of trait mindfulness. Possible scores range from 25 to 175 with higher scores reflecting higher resilience. For this study, a larger score on the Resilience Scale demonstrates a better outcome for the group performing the meditation intervention.
Assessment on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, with Mindful Attention Awareness Scale (MAAS)
Checking potential increase or decreases on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, during pregnancy using the MAAS as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Mindful Attention Awareness Scale is the unidimensional scale that consists of 15 questions concerning attention or awareness in routine situations to be rated on a 6-point scale on how frequently or infrequently the teste experiences those situations. The Likert scale ranged from (1) almost always to (6) almost never, with higher scores reflecting higher levels of trait mindfulness. The lowest possible value to be achieved when answering this scale is 15 and the highest possible value is 90. For this study, a larger score on the MAAS scale demonstrates a better outcome for the group performing the meditation intervention.

Full Information

First Posted
February 27, 2019
Last Updated
March 8, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03873194
Brief Title
Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
Official Title
Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.
Detailed Description
Primary research question: Can meditation decrease the mean increase in diastolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation? Secondary research question: Can meditation decrease the mean increase in systolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation? Does meditation practice increases (or decreases) the likelihood of change in Resilience indicators? Does meditation practice increase (or decrease) the likelihood of change in anxiety and depression indicators? Does meditation practice increase (or decrease) the likelihood of change in mindfulness indicators? Does meditation practice increase (or decrease) the likelihood of change in quality of life indicators?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced, Hypertension in Pregnancy, Hypertension
Keywords
systemic arterial hypertension, hypertension, hypertension, pregnancy-induced, pre-eclampsia, meditation, randomized clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The objective of this study is assess the effect of meditation as a complementary therapy in hypertensive pregnant women. The method used will be a randomized, controlled and blinded clinical trial, where meditation is going to be offered between March 2019 and July 2020 at the Obstetrics Clinic of Hospital of Clinics, Faculty of Medicine, University of São Paulo. Patients are going to be randomly assigned to two groups: Group I, patients who are going to practice meditation and Group II, patients that will receive only the usual outpatient care. The allocation will be performed according to CONSORT criteria and sequential within two classifications of diastolic blood pressure values. Differences between the means of the variables (blood pressure levels and questionnaires about life quality, anxiety, resilience and mindfulness) will be compared between the groups. Values of p<0,05 will be considered significant.
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinding will be used in the following manner: after informed consent, an auxiliary researcher will randomly allocate participants to 2 research groups (Group A or Group B). After this step, the auxiliary researcher will collect data for the study and will refer the patient for the usual treatment or for the usual treatment and also meditation. The lead researcher will not have access to the data that was collected at the beginning of the study by the auxiliary researcher before the end of the intervention step. He will analyse the results without knowing which patients were in which group (A or B). Only after statistical analysis the groups composition will be revealed.
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation group
Arm Type
Experimental
Arm Description
Patients who are going to practice meditation and will receive only the usual outpatient care, with the aim of observing reduction of systemic blood pressure in this period.
Arm Title
conventional treatment
Arm Type
Other
Arm Description
Patients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period.
Intervention Type
Other
Intervention Name(s)
Meditation
Intervention Description
Participants will be instructed to find a comfortable position, with a straight back, feeling the general state of their bodies (tensions, pains, heat, cold, etc.), to relax and pay attention to their own breathing, being aware of the air that gets into and out of the lungs. The women will be told that whenever their attention disperses (to another focus such as a thought, a sound, a body sensation, a judgment, etc.) they should go back to the original focus (breathing) with no feeling/judgment about the loss of focus. The practice involves focus and attention exercises and the gradual insertion of other anchors (focus points) as participants improve their skills in this practice.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
Early prenatal care, when possible, is recommended as the first measure. Prenatal appointments usually take place fortnightly or weekly for hypertensive pregnant women. Extensive lab testing including specific tests for the first trimester, as well as tests for the diagnosis of superimposed pre-eclampsia and for the evaluation of lesions in target organs. Drug treatment is only used when non-drug measures against hypertension are inefficient to decrease blood pressure levels and diastolic pressure is 90 mmHg or higher (in the first half of pregnancy) and over 100 mmHg (after 20 weeks).
Primary Outcome Measure Information:
Title
Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
Description
Diastolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
Time Frame
8 weeks
Title
Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
Description
Systolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The systolic pressure check will be in outpatient consultation with intervals of 15 days, during. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.
Description
Checking potential increases or decreases in the quality life indicator during pregnancy using the Whoqol-Bref questionnaire as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. This questionnaire is composed of four domains of quality of life, totaling 24 questions. The answers follow a Likert scale (from 1 to 5) and the domain scores for the WHOQOL-BREF were calculated by multiplying the mean of all items included within the domain by four. Potential scores for all domain scores, therefore, range from 4-20. Only the total quality of life score will be considered in this study. For this study, a larger score on the Whoqol-Bref demonstrates a better outcome for the group performing the meditation intervention.
Time Frame
8 weeks
Title
Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).
Description
Checking potential increase or decreases of anxiety and depression indicators during pregnancy using the HADS Scale as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Hospital Anxiety and Depression Scale (HADS) consist of 14 questions. It was divided into an Anxiety subscale (HADS-A) consist of 07 questions and a Depression subscale (HADS-D) consist of 07 questions both containing seven intermingled items. Each items can be scored from zero (0) to three (3), composing a maximum score of 21 points for each sub-scale. HAD-anxiety: no anxiety from 0 to 8, with anxiety ≥ 9; HAD-depression: without depression from 0 to 8, with depression ≥ 9. For this study, a larger score on the Resilience Scale demonstrates a worst outcome for the group performing the meditation intervention.
Time Frame
8 weeks
Title
Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.
Description
Checking potential increase or decreases of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress, during pregnancy using the Resilience Scale as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Resilience Scale is the scale that consist of 25 questions concerning the capacity to adapt and restore equilibrium to their lives to be rated on a 7-point scale The Likert scale ranged from (1) disagree to (7) agree, with higher scores reflecting higher levels of trait mindfulness. Possible scores range from 25 to 175 with higher scores reflecting higher resilience. For this study, a larger score on the Resilience Scale demonstrates a better outcome for the group performing the meditation intervention.
Time Frame
8 weeks
Title
Assessment on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, with Mindful Attention Awareness Scale (MAAS)
Description
Checking potential increase or decreases on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, during pregnancy using the MAAS as a result measure. The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks. The Mindful Attention Awareness Scale is the unidimensional scale that consists of 15 questions concerning attention or awareness in routine situations to be rated on a 6-point scale on how frequently or infrequently the teste experiences those situations. The Likert scale ranged from (1) almost always to (6) almost never, with higher scores reflecting higher levels of trait mindfulness. The lowest possible value to be achieved when answering this scale is 15 and the highest possible value is 90. For this study, a larger score on the MAAS scale demonstrates a better outcome for the group performing the meditation intervention.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-existing hypertension. Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension. Prenatal follow-up in a high-risk pregnancy clinic. No personal background of depression or psychiatric disorders. No serious heart disease. No illicit drugs and/or alcohol use. Acceptance of the informed consent. To follow the practice used in the study, the subjects are required to have an available phone in order to download an app which contains an audio guide for this purpose. Exclusion Criteria: Diagnosis of depression and psychiatric disorders during pregnancy. Patients who do not return to follow-up or who want to quit the study. To practice meditation.
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

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